MAUDE Adverse Event Report: STRYKER GMBH LOCKING DRILL SLEEVE, LONG IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514280
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during cssd washing the ¿plastic¿ section of the sleeve was found to be cracked and split.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned with a broken plastic handle / adapter.Visual inspection: the locking drill sleeve, long imn instruments was returned with a cracked plastic handle.This plastic handle also presents the counterpart for the tissue protection sleeve, long imn instruments ø9mm [locking mechanism of the whole sleeve assembly].Signs of damage at that area, like imprints from hitting or other kinds of mishandling were not apparent.The remaining plastic appearance was in good condition.No other deficiencies determined.Finally, although damaged it could be assembled with returned counterpart.Functional inspection: refer to visual inspection.Dimensional inspection: manufacturing and inspection records confirmed the item had been released in accordance to specs.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.With given available information and since nothing was reported during former pre-functional check or after last surgery it could not be excluded that¿s rather related to reprocessing steps performed.However, an exact root cause could not be determined since individual cleaning steps remained unknown.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported that during cssd washing the ¿plastic¿ section of the sleeve was found to be cracked and split.

• Brand Name: LOCKING DRILL SLEEVE, LONG IMN INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18082274
• Report Number: 0009610622-2023-00394
• Device Sequence Number: 7729926
• Product Code: LXH
• UDI-Device Identifier: 07613327368178
• UDI-Public: 07613327368178
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 23514280
• Device Lot Number: KP478079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown